New rotavirus vaccines close to rollout

Different formulations might have overcome problems with the previous version, but experts warn that it could take a while to rebuild trust and ensure uptake.

By Victoria Stagg Elliott, AMNews staff. Feb. 27, 2006.

Most winter days, the hospital emergency department where Paul A. Offit, MD, works as a pediatric infectious disease specialist is filled with 30 to 35 desperately ill infants and small children sickened by rotavirus.

"I'm dealing with the disease every day, and it's the second most common issue in the winter months," said Dr. Offit, chief of the division of infectious diseases at the Children's Hospital of Philadelphia.

But this regular occurrence soon may be a thing of the past. Two vaccines, including one developed in part by Dr. Offit, have demonstrated efficacy and high levels of safety against this virus.

According to two large studies involving tens of thousands of children from around the world, both an attenuated human rotavirus vaccine and a pentavalent human-bovine reassortant vaccine proved to reduce the incidence of disease dramatically without causing any adverse events. The results were published in the New England Journal of Medicine last month.

Action is now being taken in the regulatory and public health arenas to get these vaccines into medical practice. Specifically, on Feb. 3 the Food and Drug Administration approved Rotateq, a human-bovine version of the vaccine manufactured by Merck & Co.

Additionally, GlaxoSmithKline is expected to apply shortly for FDA's nod for its attenuated vaccine, which is already approved in more than a dozen countries around the world. Also, how a rotavirus vaccine should be used is on the February meeting agenda for the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.